The U.S. Food and Drug Administration (FDA) has submitted a brief detailing its appeal of Judge Amit Mehta’s decision to vacate the Deeming Rule. The Deeming Rule contains a set of guidelines by which premium cigars are regulated, and the FDA is determined to enforce it. This appeal was submitted to the U.S. Court of Appeals for the District of Columbia.

In September 2023, the FDA filed a motion to appeal Judge Mehta’s decision. The cigar industry has been vocal about its opposition to the Deeming Rule. The industry is represented by three trade associations: the Cigar Association of America (CAA), the Cigar Rights of America (CRA), and the Premium Cigar Association (PCA). However, the FDA is standing firm on its position that premium cigars need to be regulated. There are two main grounds the FDA is appealing on:

1. FDA Reasonably Concluded that There Is No Public Health Justification for Leaving Premium Cigars Entirely Unregulated.

The FDA is doubling down on its insistence that premium cigars need to be regulated. Its position is that regulating premium cigars rather than creating a special exemption for premium cigars benefits public health. It continues to insist that youth and young adults consume premium cigars.

2. If the Court Were Nevertheless To Find the Deeming Decision Insufficiently Reasoned with Respect to Premium Cigars, the Proper Remedy Would Be Remand Without Vacatur.

The FDA asserts that even though the court ruled the Deeming Rule was insufficient, the Court should have ordered the FDA to go back and fix the rule instead of vacating it. The agency also said remand with vacate is warranted because vacatur hampers Congress’s efforts to address the public health harms caused by tobacco products.

The cigar industry is now on the clock to file a response to the briefing. You can read the full text of the FDA appeal of the Deeming Rule being vacated here.